The Phase 3 SHP643-301 study evaluating the safety profile and pharmacokinetics of TAKHZYRO® (lanadelumab) in patients 2 to <12 years of age is complete and has met its objectives. The safety profile was consistent with that seen in the clinical program for patients 12 years of age and older; there were no serious adverse events and no dropouts due to adverse events.
The study also successfully reached the secondary objective evaluating the clinical activity/outcome of TAKHZYRO in preventing HAE attacks as well as characterizing the pharmacodynamics of TAKHZYRO in pediatric subjects 2 to <12 years of age.
“We are encouraged by these results, as each objective met instills further confidence in the potential to bring a treatment option to this vulnerable population,” says Ashley Yegin, Global Medical Unit Head, HAE, Global Medical Affairs, Takeda. “With more than a decade of experience and innovation in HAE, Takeda is committed to continued support for patients of all ages with this devastating condition.”
“I’m pleased that TAKHZYRO has met these key objectives and I look forward to Takeda sharing further insights with the HAE community in the near future,” says Dr. Marcus Maurer, Professor of Dermatology and Allergy Charité – Universitätsmedizin Berlin, Germany and principal investigator of SHP643-301.
Participants aged 2 to < 6 years received lanadelumab at a dose of 150 milligrams (mg) every 4 weeks (q4wks) over 52-week treatment period. Participants aged 6 to <12 years received lanadelumab at a dose of 150 mg every 2 weeks (q2wks) over 52-week treatment period. This study is complete, and full results will be presented at upcoming medical meeting(s).